While you were unwrapping presents over your long Christmas vacation, genetically engineered salmon have met the final stage of FDA approval.

The Aquabounty’s salmon will be the first GE Animal approved for human consumption.

In April 2012, the FDA met assessments by all relevant agencies for approval but was blocked by congress because of safety and environmental concerns.

Last week, the White House has rescinded its order to block the FDA from Aquabounty’s GE Salmon approval.

One of the most concerning issues is the genetic integrity of the food chain. These genetically modified and engineered fish will be introduced into the natural eco system and mate with regular breeds and continue to create hybrid breeds, never being tracked. Another concern is that this salmon will not be labeled so consumers won’t know what they are buying.

Can you take action to keep genetically engineered salmon out of the U.S.? Yes!

Click here to enter your zip code and find your congressman(woman). I wrote up this letter – simply copy and paste! Then pat yourself on the back and spread the word!

Dear Congressman,

I urge you to direct the FDA to reject the approval of Aquabounty's GE Salmon. The FDA does not currently have adequate safety testing to ensure that these animals will be safe for human health, wild fish populations and the environment.

Worst of all, while consumers have a right to know what's in their food and how it's being produced, under current law, these genetically engineered salmon would not have to be labeled.

There are numerous studies that address and support the health risks associated with, and evidenced by, unprecedented cancer rates caused by long term consumption of GMOs by laboratory animals.

There are long term studies that demonstrate the irrevocable and negative impacts on native populations of species (such as Africanized bees).

These genetically engineered animals should be rejected for consumer and environmental safety reasons.

It’s not just illegal drugs that are associated with violent and aggressive behavior. A well documented correlation exists with many popular drugs (mainly antidepressants/antipsychotic) and acts of hostility, aggression and violence towards others (and ones-self). These pharmaceutical drugs which carry ‘black box’ warnings are increasing in the rate prescribed to adults and children in the US. Should we be surprised to be witnessing an increase in violence in our community and schools?

Increase in diagnosis and drug use

The bible for mental health professionals (psychiatrists, psychologists, etc),‘The Diagnostic and Statistical Manual’(DSM-5), makes it easy to fit every person and child into neatly defined categories of ‘mental illness’ and once a person is labeled with a specific mental illness(es) they can be prescribed powerful anti-psychotic drugs (even to children as young as 3 years of age) that may or may not be associated with violent or suicidal behavior.

The new revision for the DSM-5 will be published in May of this coming year (2013) and we are guaranteed to witness an increase (specifically in children) that are diagnosed with disorders that are treated with drugs that are associated with aggression. This increase will be to due to more lienant criteria to meet certain diagnoses (such as ADD and anxiety) and many new ‘disorders’ focused on children such as Disruptive Mood Dysregulation Disorder. (If you have yet to read about DMDD may I suggest you do so- here is a good article that provides research that illustrates many flaws of this 'diagnosis' of kids with temper tantrums.)

Am I suggesting that mental health professionals are purposefully trying to push dangerous drugs on as many people as possible – absolutely not. These professionals are trying to help everyone that needs it, however, I think we need to be exceptionally cautious in three area of mental illness management: diagnosis, treatment, and long term use of pharmaceuticals.

What you can do

If you are considering using or giving your child a drug, check out MedWatch in addition to talking to your doctor. This website is the FDA’s reporting system for adverse events and recalls associated with pharmaceutical drugs. There have been over 11,000 reported events to MedWatch for psychiatric drug side effects related to violence (between 2004-2011).

Speaking specifically to violence and aggressive behavior, check out RxIsk.org. On the website there is a section titled Violence Zone which allows you to enter the name of a drug and see the side effects relating to violence. The data is sorted in organized tables, heat maps, and tag clouds – even interactive graphs that show you what is happening with others taking that same drug around the globe.

RxIsk is a great resource. It is owned by the Data Based Medicine Americas (based in Toronto) and has an international reputation for finding early drug-side effects and risks.

If you are experiencing a side effect due to a pharmaceutical drug – please report it! Drug side effects are a leading cause of death and injury, yet less then 5 percent of serious side effects are reported.

Also, consider signing this petition which is targeting the Committee on Oversight & Government Reform. The petition is asking lawmakers to require an investigation into the role of psychiatric drugs and violence in relation to school shootings and similar acts of violence.

Top 10 associated with violence

Research published last year from ISMP (The Institute for Safe Medication Practices) raised concerns about violent side effects of some very popular antipsychotic drugs (most of which are antidepressants).

This list was reported in Time magazine which can be found here and read to its entirety. I also suggest reading the actual published research found here.

10. Desvenlafaxine (Pristiq) An antidepressant which affects both serotonin and noradrenaline, this drug is 7.9 times more likely to be associated with violence than other drugs.

9. Venlafaxine (Effexor) A drug in the class of antidepressants, it used to treat anxiety disorders. Effexor is 8.3 times more likely than other drugs to be related to violent behavior.

8. Fluvoxamine (Luvox) An antidepressant that affects serotonin (SSRI), Luvox is 8.4 times more likely than other medications to be linked with violence

7. Triazolam (Halcion) A benzodiazepine which can be addictive, used to treat insomnia. Halcion is 8.7 times more likely to be linked with violence than other drugs, according to the study.

6. Atomoxetine (Strattera) Used to treat attention-deficit hyperactivity disorder (ADHD), Strattera affects the neurotransmitter noradrenaline and is 9 times more likely to be linked with violence compared to the average medication.

5. Mefoquine (Lariam) A treatment for malaria, Lariam has long been linked with reports of bizarre behavior. It is 9.5 times more likely to be linked with violence than other drugs.

4. Amphetamines: (Various) Amphetamines are used to treat ADHD and affect the brain’s dopamine and noradrenaline systems. They are 9.6 times more likely to be linked to violence, compared to other drugs.

3. Paroxetine (Paxil) An SSRI antidepressant, Paxil is also linked with more severe withdrawal symptoms and a greater risk of birth defects compared to other medications in that class. It is 10.3 times more likely to be linked with violence compared to other drugs.

2. Fluoxetine (Prozac) The first well-known SSRI antidepressant, Prozac is 10.9 times more likely to be linked with violence in comparison with other medications.

1. Varenicline (Chantix) The anti-smoking medication Chantix affects the nicotinic acetylcholine receptor, which helps reduce craving for smoking. Unfortunately, it’s 18 times more likely to be linked with violence compared to other drugs.

Conclusion

The research reported by the ISMP is valid and raises genuine concern about adverse violent events associated with a particular small group of drugs (of which many are given to children).

It is also significant to state that this report utilizes data from MedWatch which the FDA acknowledges only holds a fraction (1-5%) of side effects because of acute under-reporting.

Please read more about any prescription drug(s) you are considering on using, both on yourself or your child. Consider mentioning these websites if someone you love is using a prescription drug in their recovery process. Also, please contact a healthcare professional if someone you know starts acting aggressively, being disturbingly angry or shows violence to others or themselves.

This post is a continuation of a series that will be providing information on each disease and vaccine that is currently on the CDC’s recommended national immunization schedule.I hope this information is able to help those attempting to decide on an alternative vaccine schedule (whether that is a delay, select or decline one). Please leave a comment if you have any questions.

The information below is gathered from sources included PubMed, the CDC, the Mayo Clinic, and package inserts published from the vaccine manufacturer. (See below for a full list)

Polio or Poliomyelitis is derived from two Greek words: polio (grey) and myelon (marrow of the spinal cord). This name illustrates the effect poliomyelitis virus has on the spinal cord which leads to the characteristic paralysis we all associate with the disease. Interestingly, 95% of polio infection is subclinical meaning that the virus causes no symptoms.

The poliovirus is a member of the enterovirus subgroup which means that it has the ability to multiply in the gastrointestinal tract and is stable at an acid pH.

Humans are the only known reservoir for the virus.

Prevalence

At one point, transmission of poliovirus infection occurred around the globe. It has now been declared eradicated in the western hemisphere. Currently Pakistan, Afghanistan and Nigeria are the only countries where poliovirus is labeled as endemic (living within a geographical area).

It is known that the ecology and herd immunity characteristics of polioviruses are heavily dependent upon levels of hygiene (pg 290). The poliovirus will mainly infect children under 5 years old and populations living in socioeconomically disadvantaged areas, where sanitation is poor and access to clean water is limited.

Wild polio viruses ceased to circulate in most of the United States by 1970, at which time only 65 percent of children were receiving a complete course of live oral polio vaccine. (Pg 290)

From 1923 to 1953, before the Salk killed-virus vaccine was introduced, the polio death rate in the United States and England had already declined on its own by 47 percent and 55 percent, respectively. Source: International Mortality Statistics (1981) by Michael Alderson.

Complications

A person’s response to a poliovirus infection can be highly variable and is categorized on the severity of their symptoms.

Nearly 95% of all poliovirus cases are asymptomatic or inapparent and less then 1% will lead to flaccid (reduced muscle tone) paralysis. Many people with paralytic polio will recover completely and the majority will experience muscle function return in various degrees.

1-2% of infected individuals will suffer from nonparalytic aseptic meningitis (stiffness of the neck, back or legs). Typically these symptoms will last from 2 to 10 days followed by a complete recovery.

Death rates for paralytic polio cases (remember this is <1% of cases) are approximately 2-5% for children with higher numbers seen in adults (15-30%).

The Vaccines

I will only be discussing in detail the IPV (injectable polio) vaccines since the OPV (live, oral polio) vaccine is no longer employed in the US since 2000. This is due to the efforts to eliminate VAPP (vaccine-associated paralytic polio, aka polio caused by the oral vaccine).

It is believed that 90 percent of individuals who receive the polio vaccine will develop antibodies to all three polio virus types after two doses with 99% following the third dose. Protection is assumed and correlated with the presence of antibodies.

Because the injectable vaccine (IPV) produces less gastrointestinal immunity then the oral vaccine, persons who complete the schedule with the IPV are more readily infected with wild-type polio then OPV recipients.

Duration of immunity from IPV is not known, however it is assumed to provide “many years” of protection after the complete series is finished (according to the CDC).

There are three combination vaccines doctors use in the US that contain the inactivated polio vaccine. The acceptable schedule approved by the ACIP for IPV consists of four doses (2 months, 4months, 6-18 months, and 4 years). The first three doses are routinely administered with other vaccines.

IPOL (Sanofi Pasteur)

IPOL is the only singleton polio vaccine and can be used in children 6 weeks old to adulthood.

According to the package insert, interruption of the recommended schedule with a delay between doses does not interfere with the final immunity. There is no need to start the series over again, regardless of the time elapsed between doses.

Pediarix (GlaxoSmithKline)

Pediatrix contains DtaP, hepatitis B and IPV – this vaccine can be used for the first 3 doses (2month, 4month, 6-18 months) of the DtaP series among ages 6weeks through 6 years.

The safety study performed in the US for licensure consisted of a control group (335 infants) receiving the Hib conjugate vaccine (Wyeth; no longer licensed in the US) and 7-valent pneumococcal conjugate vaccine (Wyeth). No saline solution group was employed.

The rate of fever (greater then 100.4 degrees F) is significantly higher in the group that received Pediarix compared to separately administered vaccines. Other statistically significant adverse events include: pain, redness, swelling, drowsiness, irritability, and loss of appetite.

It is noted in the package insert that some cases of SIDS can be expected to follow receipt of pertussis-containing vaccines.

Kinrix (GlaxoSmithKline)

Kinrix contains DtaP and IPV – this vaccine is approved for children 4 yrs-6yrs which means that Kinrix is normally employed for the 5th dose of DtaP and fourth dose of IPV.

Adverse side effects reviewed in the clinical trials that were statistically significant were pain (statistically higher compared to IPOL), redness, swelling, drowsiness, loss of appetite and fever (statistically higher compared to IPOL). The placebo group used in clinical trials to assess safety was IPOL+Infanrix. No saline solution group was employed.

Pentacel (Sanofi Pasteur)

Pentacel contains DtaP, Hib and IPV – when this vaccine is used to provide the recommended 4 doses, an additional booster dose is suggested at age 4-6 years. This will result in a 5-dose IPV series.

Pentacel is the most reactive vaccine for polio. Serious adverse events 30 days after vaccination were reported more often then any other control groups in the safety assessment. Of these adverse reaction, events reported consist of: bronchiolitis, dehydration, pneumonia, asthma and gastroenteritis.

OPV

All of the vaccines listed above are inactivated poliovirus vaccines which do not contain live viruses, so they cannot cause VAPP (vaccine associated polio paralysis). However, the oral polio vaccine (OPV) is still administered to children and adults in countries around the world.

It is said that the advantages of using OPV in developing nations seem to outweigh the risk of vaccine-induced polio (the OPV is more cost effective). However, mutant strains (virus revertants) of vaccine-virus polio have been reported and have infected people in Hispaniola, the Philippines and Madagascar.

SV40 Contamination

SV40 (simian vacuolating virus 40) is a DNA-virus found in monkeys that has the potential to cause tumors. It was discovered in 1960, that same year SV40 was found to contaminate IPV vaccines.

That next year, in 1961, the virus was found to cause tumors in rodents. Following that discovery, the US government required new stocks of polio vaccine free of SV40.

The contaminated vaccines were not recalled and continued to be used for 3 more years following the discovery. Over 98 million US citizens received at least one dose of polio vaccine contaminated with SV40.

The current inactivatd polio vaccines (IPV) are free of contamination that we are curretly able to test for.

Whenever you make a health care decision for yourself or your child, especially one that involves a pharmaceutical product such as a vaccine, you should consider obtaining information from many different sources as well as consulting your health care professional.

Becoming an informed health care consumer is important and will empower you to ask doctors important questions and ultimately help you to take control of your health choices.

If your doctor is not supportive of your informed health choices, consider consulting another doctor who will work with you as a partner helping you make important health care decisions for yourself or your child(ren).

Information presented on this post can be reviewed in depth from the following sources:

This post is a continuation of a series that will be providing information on each disease and vaccine that is currently on the CDC’s recommended national immunization schedule.I hope this information is able to help those attempting to decide on an alternative vaccine schedule (whether that is a delay, select or decline one). Please leave a comment if you have any questions.

The information below is gathered from sources included PubMed, the CDC, the Mayo Clinic, and package inserts published from the vaccine manufacturer. (See below for a full list)

According to the CDC, rotavirus is the most common cause of diarrhea in children and infants across the globe. The majority of children will experience at least one rotavirus infection by 2 or 3 years of age.

There are many different strains of the rotavirus however five strains account for nearly 90 percent of human infections in the US and other developed countries (there is more diversity seen in developing countries).

Once a child has been infected with a rotavirus strain, antibodies are produced and a child is either immune for life or has a milder case after re-infection. The majority of healthy children who are infected with rotavirus strains within the first years of life will develop lifelong natural immunity to infection.

According to the CDC, 20 to 60 deaths occur annually in the US due to rotavirus infection.

Transmission

Several days prior to symptoms occur and up to 10 days after symptoms recede, the rotavirus is easily spread via hand-to-mouth contact through infected individuals stools -another reason that it is imperative to your health (and your children) to learn an excellent hand washing routine. The virus lives on hands for hours and even longer on hard surfaces.

Risk of infection is most common between 4 months – 24 months. Children who are in group care settings also have an elevated risk.

In non-tropical climates, such as the US, rotavirus infection seems to be highest in winter and spring months.

Symptoms

In healthy adults, a rotavirus infection may only cause mild symptoms or none at all. In children, the infection will start with an onset fever, followed by watery diarrhea and in some cases vomiting. This can last anywhere from 3 days to a week.

After a child has been infected once, they can be infected again due to the several strains circulating, however subsequent infections are not as serious as the first.

The principal concern of rotavirus is dehydration, especially in young children. This concern is particularly important in developing countries.

Treatment

In children, rotavirus can be unpleasant and treatment focuses on providing extra fluids to prevent dehydration.

Breast milk is ideal in treatment and prevention since it has shown in many studies to specifically protect babies from rotavirus infection. If you are not breastfeeding you can offer electrolyte solutions along side formula feedings.For older children, you can eliminate/limit/avoid sugary drinks, dairy products and juice which can make diarrhea worse.

Remember, antibiotics have no effect on rotavirus.

The Vaccine

The rotavirus vaccine is not mandated or required for school entry in any US state.

There are two live oral rotavirus vaccines approved for use in the US. Each one differs slightly in their manufacturing process and the doses prescribed. The CDC recommends administering the rotavirus vaccines at the same time as other vaccines at that age group.

Please note, according to the ACIP and CDC, vaccination should NOT be started on infants 12 weeks or older because of lacking safety data of first dose in older infants. In this case, if you delay this vaccine until 12 weeks, then your child should not receive it at all.

RotaTeq

RotaTeq is manufacturer by Merck (invented by H. Fred Clark and Paul Offit) and was approved for use in the US by the FDA in 2006. It is given by mouth in three doses (2 months, 4 months and 6 months). The vaccine is manufactured by genetically engineering a vaccine made of five live attenuated human-bovine (cow) hybridized reassorted rotaviruses. It contains polysorbate 80 and trace amounts of fetal bovine (cow) serum.

This vaccine does not contain preservatives.

On March 22, 2010, the FDA announced that Rotateq was found to be contaminated with foreign DNA from two porcine (swine/pig) circoviruses: PCV1 and PCV2. The PCV2 is a fatal pig virus which causes immune suppression in baby pigs (damaging lungs, brain, kidney, and the reproductive system). The FDA suggested a temporary postponement of Rotateq. However, a little over a month later on May 7, 2010, the FDA lifted the recommendation. No adjustment was made to the vaccine; instead the FDA stated that they are working with Merck to update the labeling on vaccines to include information about the presence of PCV1 and PCV2 in the vaccine.

Intussusception (a rare but life-threatening form of intestinal blockage) has been reported after vaccination with Rotateq. Another rotavirus vaccine called RotaShied was revoked from the US market in 1999 because of the association with increased cases of intussusception. However, the CDC and FDA state that the number of cases reported following Rotateq is similar to the cases found in unvaccinated children.

The estimated effectiveness against rotavirus cases after completely the 3 doses of Rotateq is about 74 percent and about 98 percent of severe cases.According to the manufacturer’s package insert, the vaccine may not protect all vaccine recipients.

Some of the more common side effects after administering Rotateq is diarrhea, irritability, vomiting and otitis media (ear infection).

Additions to package insert and public health notifications: In 2007, the FDA issued a Public Health Notification on Rotateq when reports where confirmed of intussusception after vaccination. Approximately half of the cases occurred 1 to 21 days after vaccination.

One month later the CDC reversed the statement by the FDA and issued a new statement stating that postmarketing surveillance data does not suggest that Rotateq is associated with intussusception. The number reported did not exceed the expected background cases.

In June 2007, a label change was approved by the FDA for Rotateq to include Kawaski syndrome which is an inflammation of blood vessels occurring in five cases before licensure and three following licensure.

Rotarix

Rotarix is manufactured by GlaxoSmithKline and was licensed by the FDA in 2008. It is administered in two doses (2 months and 4 months of age). The Rotarix vaccine is genetically engineered out of live attenuated human rotaviruses.

On March 22, 2010, the FDA temporarily suspended use of the Rotarix vaccine in the US because an extraneous virus (PCV1) was found to be contaminating the solution. (Compared to Rotateq – which was only suggested to postpone use NOT completely suspended). The suspension was revoked on May 7th of that year and GlaxoSmithKline pledged to reformulate the Rotarix vaccine and remove PCV1 DNA.

No date was given for when the Rotarix vaccine will be free of contamination.

The estimated effectiveness of the Rotarix vaccine (according to the New England Journal of Medicine) is 85 percent and reached 100 percent against severe rotavirus gastroenteritis.

More common reactions that are reported are temporary diarrhea, fussiness, fever, loss of appetite, vomiting and cough/runny nose.

Included in the manufacturers insert for Rotarix, reports of infants with intussusception following vaccinated has been received by VAERS.

Live Vaccines

Since RotaTeq and Rotarix are live vaccines, the manufacturers acknowledge it is possible to transmit the vaccine strain virus to others who come in contact with a recently vaccinated child.

RotaTeq: “RotaTeq is a solution of live reassortant rotaviruses and can potentially be transmitted to persons who have contact with the vaccine. The potential risk of transmission of vaccine virus should be weighed against the risk of acquiring and transmitting natural rotavirus.”

Rotarix: “There is a possibility that the live vaccine virus can be transmitted to non-vaccinated contacts. The potential for transmission of vaccine virus following vaccination should be weighed against the possibility of acquiring and transmitting natural rotavirus.”

Whenever you make a health care decision for yourself or your child, especially one that involves a pharmaceutical product such as a vaccine, you should consider obtaining information from many different sources as well as consulting your health care professional.

Becoming an informed health care consumer is important and will empower you to ask doctors important questions and ultimately help you to take control of your health choices.

If your doctor is not supportive of your informed health choices, consider consulting another doctor who will work with you as a partner helping you make important health care decisions for yourself or your child(ren).

Information presented on this post can be reviewed in depth from the following sources: